Study to Assess the Prognostic Value of the Antithrombin III in the Acute Pancreatitis (AT-PROPANC)

NCT ID: NCT02373293

Last Updated: 2017-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-18

Study Completion Date

2017-08-31

Brief Summary

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This is an epidemiological, observational, prospective, multicentric study in 400 adult patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value of the antithrombin III in the development of moderate or severe acute pancreatitis.

Detailed Description

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This is an epidemiological, observational, prospective, multicentric study in 400 adult patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value of the antithrombin III in the development of moderate or severe acute pancreatitis.

In the context of clinical practice of general surgery and apparatus digestive services, patients entering with mild acute pancreatitis will be asked to participate in the study and if so, they will sign the informed consent.

On admission, demographic and anthropometric data of the patient will be recorded, as well as medical history, patient's admission data and vital signs. Patient's blood will be drawn for analysys and the risk of organ failure will be measured by modified Marshall and Apache II scales. The assessments and procedures performed are the standard practice at the center.

At 24 hours (± 3 hours) and at 7 days (or nine days to avoid weekends) after admisison, vital signs will be recorded, laboratory tests will be performed and the risk of organ failure will be measured by modified Marshall and Apache II scales.

At discharge of the patient (regardless of when it occurs), the outcome of the acute pancreatitis will be recorded.

. Those patients discharged within the first month after admission will be visited or called (according to standard practice at the center) one month after arrival, to record follow-up data, including health condition, readmissions and abdominal pain evaluation by visual analog scale.

Conditions

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Acute Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with mild acute pancreatitis according to seriousness criteria established by Banks et al, 2013.
* Patients of either sex aged ≥ 18 years .
* Patients who have given their written informed consent

Exclusion Criteria

* Patients with exacerbated chronic pancreatitis.
* Patients with coagulation disorders (congenital and acquired antithrombin deficiency) .
* Patients with liver cirrhosis.
* Pregnant patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alclinical Research, S.L.

UNKNOWN

Sponsor Role collaborator

Francisco Javier García Borobia

OTHER

Sponsor Role lead

Responsible Party

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Francisco Javier García Borobia

Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Francisco Javier García Borobia, Dr.

Role: PRINCIPAL_INVESTIGATOR

Corporacion Parc Tauli

Locations

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Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Site Status RECRUITING

Hospital de Sant Joan Despí Moisés Broggi

Sant Joan Despí, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Francisco Javier García Borobia, Dr.

Role: CONTACT

+34 93 7231010 ext. 21461

Facility Contacts

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Francisco Javier -García Borobia, Dr.

Role: primary

+34 93 7231010 ext. 21461

Robert Memba, Dr.

Role: primary

References

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Garcia Borobia F, Flores Clotet R, Bejarano Gonzalez N, Gonzalez Martinez S, Garcia Monforte N, Romaguera Monzonis A, Gonzalez Abos C, Gonzalez Abos S, Lucas Guerrero V, Perez Perarnau A, Mota Villaplana F. Predictive Value of Antithrombin III and d -Dimer in the Development of Moderate-To-Severe Acute Pancreatitis : A Prospective, Observational Study (AT-PROPANC). Pancreas. 2023 Apr 1;52(4):e241-e248. doi: 10.1097/MPA.0000000000002245. Epub 2023 Sep 20.

Reference Type DERIVED
PMID: 37801622 (View on PubMed)

Other Identifiers

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GAR-BOR/TAULI-2013

Identifier Type: -

Identifier Source: org_study_id

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